PATIENT INFORMATION LEAFLET

PRAVASTATINA KORHISPANA 10 mg tablets EFG

Pravastatin sodium

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Pravastatina Korhispana are tablets that contain pravastatina sodium as the active ingredient, available in the market in the following dosages: 10 mg, 20 mg and 40 mg. It is included in the category of anti-dislipidemics.

Therapeutic indications

Hypcholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, in conjunction with diet, when the response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) has failed.

Primary prevention

Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia and high risk of a first cardiovascular event, as an additional treatment to diet.

Secondary prevention

Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina and with normal or elevated cholesterol levels, in conjunction with correction of other risk factors.

Post-transplant

Reduction of post-transplant hyperlipidemia (blood lipid levels) in patients receiving immunosuppressive treatment after solid organ transplantation (see the sectionsBefore taking Pravastatina KorhispanaandHow to take Pravastatina Korhispana).

Do not take PravastatinaKorhispana:

• If you are allergic (hypersensitive) to pravastatina or any of the other components of Pravastatina Korhispana.
• If you have any active liver disease, including unexplained elevations of serum transaminases above three times the upper limit of normal (see the sectionBefore taking PravastatinaKorhispana).
• During pregnancy or breastfeeding.

Be especially careful with Pravastatina Korhispana:

In the case of familial hypercholesterolemia, since pravastatina has not been evaluated in patients with this condition.

In cases of liver disease, since, like other similar lipid-lowering drugs, moderate increases in serum transaminases levels may occur, which in most cases return to normal without the need to suspend treatment.

As with other statins, treatment with pravastatina has been associated with the appearance of muscle problems: myalgia, myopathy, and, rarely, rhabdomyolysis. The possibility of myopathy should be taken into account in any patient treated with statins and presenting unexplained muscle symptoms such as muscle pain or sensitivity, muscle weakness, or muscle cramps.

The risk and severity of muscle problems during treatment with statins increase with the concomitant administration of interacting medications. Muscle symptoms, when associated with statins, usually disappear after suspending treatment.

Consult your doctor or pharmacist before starting to takePravastatina Korhispana if you:

?Have severe respiratory insufficiency.

• Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.
• Have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), since statins can sometimes worsen the disease or cause myasthenia (see section 4).

While you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Children under 18 years:Pravastatina Korhispana is not recommended for use in children due to the limited available data on safety and efficacy in these patients.

Older adults:In elderly patients with risk factors, it may be necessary to adjust the dose.

Patients with renal or hepatic insufficiency:The dose should be adjusted according to blood lipid levels and under medical supervision.

Before starting treatment::

• It is recommended to determine creatine kinase levels before starting treatment in patients with special predisposing factors and in patients who develop muscle symptoms during treatment with statins.

• Care should be taken in patients with predisposing factors such as renal insufficiency, hypothyroidism, history of muscle toxicity from a statin or a fibrate, family history or personal history of hereditary muscle diseases, or alcohol abuse. In these cases, creatine kinase levels should be determined before starting treatment. Additionally, creatine kinase levels should be determined before starting treatment in patients over 70 years old, especially those with other predisposing factors.

During treatment::

• Patients should be advised to report any unexplained muscle pain, sensitivity, weakness, or muscle cramps promptly. In these cases, creatine kinase levels should be determined. If a hereditary muscle disease is suspected in the patient, it is not recommended to resume treatment with statins.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Fibrates::The use of fibrates alone has been associated with the appearance of myopathy. There has been a reported increase in the risk of muscle adverse reactions, including rhabdomyolysis, associated with the concomitant administration of fibrates with other statins. Since the appearance of these adverse reactions cannot be ruled out with pravastatina, it is recommended to avoid the simultaneous use of pravastatina and fibrates (e.g., gemfibrozil, fenofibrate).

Colestiramina/colestipol::The simultaneous administration resulted in a decrease in pravastatina bioavailability. When pravastatina was administered one hour before or four hours after colestiramine or one hour before colestipol and a standard meal, no clinically significant decrease in bioavailability or therapeutic effect was observed (see the sectionHow to takePravastatinaKorhispana).

Ciclosporina::The simultaneous administration of pravastatina and ciclosporin results in an increase in systemic exposure to pravastatina. It is recommended to perform clinical and biochemical monitoring in patients receiving this combination (see the sectionHow to takePravastatinaKorhispana).

Warfarina and other anticoagulants::The chronic administration of pravastatina and warfarin does not produce any change in the anticoagulant effect of warfarin.

Drugs metabolized by the cytochrome P450::Specifically, the absence of significant pharmacokinetic interactions with pravastatina and other drugs, especially those that are substrates/inhibitors of CYP3A4, such as diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice, and CYP2C9 inhibitors (e.g., fluconazole), has been demonstrated.

Special caution should be exercised when pravastatina is administered with erythromycin or clarithromycin.

Other drugs::No statistically significant differences in bioavailability were observed when pravastatina was administered in interaction studies with aspirin, antacids (one hour before pravastatina), nicotinic acid, or probucol.

Pravastatina Korhispana with food and beverages:

Pravastatina is administered once a day, preferably at night. The tablets can be taken with or without food.

Pravastatina should be administered under strict supervision in patients who consume large amounts of alcohol or have pre-existing liver disease.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Pravastatina is contraindicated during pregnancy.

If a patient plans to become pregnant, she should immediately inform her doctor and discontinue pravastatina treatment due to the potential risk to the fetus.

Pravastatina passes in small amounts into breast milk, so it is contraindicated during breastfeeding.

Driving and operating machinery:

Pravastatina has no or has a negligible effect on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness may occur during treatment.

Important information about one of the components of PravastatinaKorhispanatablets:

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Pravastatina Korhispana indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Before starting treatment with Pravastatina Korhispana, secondary causes of hypercholesterolemia must be ruled out and patients must undergo a standard hypolipidemic diet (a diet to reduce blood lipid levels), which should be maintained during treatment.

Pravastatina Korhispana is administered orally once a day, preferably at night, with or without food.

Hipercolesterolemia:The recommended dosage interval is 10 to 40 mg once a day. The response to treatment is observed after a week, with maximum effect achieved in four weeks; therefore, periodic blood lipid determinations should be performed and the dosage adjusted accordingly. The maximum dose is 40 mg per day.

Cardiovascular prevention:In all morbidity and mortality studies, the only starting and maintenance dose studied was 40 mg per day.

Posology after transplants:After an organ transplant, an initial dose of 20 mg per day is recommended in patients receiving immunosuppressive treatment. Depending on blood lipid levels, the dose may be increased to 40 mg under close medical supervision (see section Before Taking Pravastatina Korhispana).

Children:The available information on safety and efficacy in patients under 18 years is limited; therefore, the use of Pravastatina Korhispana is not recommended in these patients.

Elderly patients:No dose adjustment is necessary in these patients unless other risk factors are present (see section Before Taking Pravastatina Korhispana).

Renal or hepatic insufficiency:In patients with moderate or severe renal impairment or significant hepatic impairment, an initial dose of 10 mg per day is recommended. The dose should be adjusted according to blood lipid levels and under medical supervision.

Concomitant treatment:The cholesterol-lowering effect of Pravastatina Korhispana increases when combined with a bile acid sequestrant (e.g., cholestyramine, colestipol). Pravastatina Korhispana should be taken one hour before or at least four hours after the sequestrant (see section Before Taking Pravastatina Korhispana).

Patients treated with cyclosporine with or without other immunosuppressants should start therapy with 20 mg of pravastatina once a day, and the dose adjustment to 40 mg should be done with caution (see section Before Taking Pravastatina Korhispana).

If you estimate that the action of Pravastatina Korhispana is too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatina Korhispana than you should:

There is limited information on pravastatina overdose and its treatment. Therefore, if you have taken more Pravastatina Korhispana than you should, contact your doctor or pharmacist or the nearest hospital for appropriate symptomatic treatment.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420.

If you forget to take Pravastatina Korhispana:

Do not take a double dose to compensate for the missed dose, wait for the next scheduled dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

If you interrupt treatment with Pravastatina Korhispana:

Contact your doctor or pharmacist.

Like all medicines, Pravastatina Korhispana can cause side effects, although not everyone will experience them.

Side effects are classified as: very common (in at least 1 in 10 patients), common (in at least 1 in 100 patients), uncommon (in at least 1 in 1,000 patients), rare (in at least 1 in 10,000 patients), very rare (less than 1 in 10,000 patients), frequency not known (the frequency cannot be estimated from the available data) and isolated cases.

The side effects found during studies conducted with pravastatina 40 mg have been:

Nervous system disorders:

Uncommon: dizziness, headache, sleep disorders, including insomnia and nightmares.

Eye disorders:

Uncommon: visual disturbances (including blurred vision and double vision of objects)

Gastrointestinal disorders:

Uncommon: indigestion/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhea, gas

Skin and subcutaneous tissue disorders:

Uncommon: itching, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).

Renal and urinary disorders:

Uncommon: urinary elimination disturbances (such as difficulty urinating, urinating more frequently and urinating more frequently at night).

Reproductive and breast disorders:

Uncommon: sexual alterations.

General disorders:

Uncommon: fatigue

The possible side effects of some statins (medicines of the same type):

• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat levels, overweight and high blood pressure. Your doctor will monitor you while taking this medication.

Side effects of special clinical relevance:

Musculoskeletal disorders: muscle and skeletal pain including joint pain, muscle cramps, muscle pain (very common) and elevations of creatine kinase levels (enzyme indicative of muscle alteration).

Frequency not known:Constant muscle weakness.

Hepatic disorders: elevations of serum transaminases (enzymes indicative of liver disease).

During post-marketing experienceof pravastatina, the following adverse reactions have been reported:

Nervous system disorders:

Very rare: peripheral neuropathy, particularly when used for a prolonged period and paresthesia (tingling sensation).

Frequency not known:Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or eyelid drooping, difficulty swallowing or difficulty breathing.

Eye disorders:

Frequency not known:Myasthenic eye disease (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or eyelid drooping, difficulty swallowing or difficulty breathing.

Immune system disorders:

Very rare: hypersensitivity reactions such as swelling of the arms, legs, face, lips, tongue and/or throat (angioedema), lupus-like syndrome.

Gastrointestinal disorders:

Very rare: pancreatitis (inflammation of the pancreas)

Hepatobiliary disorders:

Very rare: yellow skin discoloration (jaundice), liver inflammation (hepatitis), fulminant liver cell destruction (fulminant hepatic necrosis).

Musculoskeletal and connective tissue disorders:

Very rare: muscle fiber destruction (rhabdomyolysis) that may be associated with acute renal failure secondary to myoglobinuria (red urine) and muscle alterations (myopathy), muscle inflammation (myositis), significant muscle weakness (polymyositis) (see section 2).

Isolated cases of tendon disorders, sometimes complicated with rupture.

Frequency not known: muscle rupture.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep Pravastatina Korhispana out of the reach and sight of children.

Do not store at a temperature above25ºC. Store in the original packaging well closed.

Expiration date:

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash.Deposit the packaging and medicines that you do not need in the SIGRE collection pointof the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Pravastatina Korhispana 10 mg tablets:

The active ingredient is pravastatina sodium. Each tablet contains 10 mg of pravastatina sodium.

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, and anhydrous disodium phosphate.

Appearance of the product and contents of the package:

Pravastatina Korhispana is presented in the form of white, oblong, convex, and scored tablets on both faces.. Each package contains 28 tablets in high-density polyethylene bottles.

Holder of the marketing authorization and responsible manufacturer:

Holder:

KORHISPANA, S.L.

Carretera de Castellvell, 24 (Reus)

- 43206 – Spain

Responsible manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora (Portugal).

This leaflet was approved in March2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/